NCT01559935 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- groups
- description
- Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
- id
- BG000
- title
- Car-BiRD Therapy
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 85
- value
- 60.4
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 85
- value
- 59.6
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 79
- value
- 59.2
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Age, Customized
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 29
- title
- Female
- measurements
- group Id
- BG000
- value
- 43
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- value
- 26
- title
- Female
- measurements
- group Id
- BG000
- value
- 32
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- value
- 23
- title
- Female
- measurements
- group Id
- BG000
- value
- 31
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 61
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 8
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 48
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 7
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- value
- 2
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 45
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 7
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 5
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 29
- title
- White
- measurements
- group Id
- BG000
- value
- 6
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 32
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 4
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 22
- title
- White
- measurements
- group Id
- BG000
- value
- 5
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 27
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 3
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 20
- title
- White
- measurements
- group Id
- BG000
- value
- 5
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 26
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- groups
- description
- Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) \[Car-BiRD\] Car Phase: carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib. BiRD Phase: Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed. Maintenance Phase: Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
- id
- BG000
- title
- Car-BiRD Therapy
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 85
- value
- 60.4
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 85
- value
- 59.6
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- lower Limit
- 42
- upper Limit
- 79
- value
- 59.2
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Age, Customized
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 29
- title
- Female
- measurements
- group Id
- BG000
- value
- 43
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- value
- 26
- title
- Female
- measurements
- group Id
- BG000
- value
- 32
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- value
- 23
- title
- Female
- measurements
- group Id
- BG000
- value
- 31
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects reached the BiRD Phase of the CarBiRD therapy. 54 subjects reached the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 61
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 8
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 48
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 7
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- value
- 2
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 45
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 7
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 5
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 29
- title
- White
- measurements
- group Id
- BG000
- value
- 6
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 32
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 72
- units
- Participants
- title
- Car Phase
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 4
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 22
- title
- White
- measurements
- group Id
- BG000
- value
- 5
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 27
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 58
- units
- Participants
- title
- BiRD Phase
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 3
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 20
- title
- White
- measurements
- group Id
- BG000
- value
- 5
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 26
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 54
- units
- Participants
- title
- Maintenance Phase
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- 72 subjects started the Car Phase of the CarBiRD therapy. 58 subjects started the BiRD Phase of the CarBiRD therapy. 54 subjects started the Maintenance Phase of the CarBiRD therapy. A detailed explanation of those numbers is provided in the participant flow.
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